August 2, 2013

FDA Sets New Rules On Gluten-Free Food Labeling

At least three million Americans who suffer from celiac disease can now feel confident knowing tha,t when they buy a product labeled "gluten-free," they are actually getting what they expect. This comes thanks to a new FDA ruling that defines exactly what "gluten-free" means.

Under the new rule, when consumers see a label that is marked "gluten-free," "without gluten," "free of gluten" or "no gluten," they can be assured that those claims have meaning, said Michael Taylor, JD, deputy commissioner for foods and veterinary medicine with the FDA.

Under the ruling, which has been in the works since 2007, foods that carry the "gluten-free" label must contain fewer than 20 parts per million of gluten. This is the lowest level that can be consistently detected in foods using scientific measuring tools. The new rule should appease advocates for people with celiac disease as well as those who have the disease.

Celiac disease is a potentially life-threatening autoimmune disorder of the small intestine. People who have this illness can have chronic pain and discomfort, diarrhea and nausea when they eat foods that contain gluten, which includes foods like bread, cake, cereal, pasta, etc. Most people who have this disease, however, can tolerate very small amounts of gluten.

Gluten is a protein that occurs naturally in wheat, rye and barley. People with celiac disease cannot digest this protein and their bodies produce antibodies that attack and damage the lining of the small intestine. If not diagnosed and treated early, it can lead to serious health problems including nutritional deficiencies, osteoporosis, infertility, miscarriage and cancers.

"[The new] 'gluten-free' definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled 'gluten-free' meet a clear standard established and enforced by FDA," said Taylor.

While celiac disease can be treated with proper diet, there is no known cure, noted Andrea Levario, executive director of the American Celiac Disease Alliance. Without a legal definition of "gluten-free," consumers would never be really sure if the food they were buying was in fact gluten-free.

"This is a tool that has been desperately needed," Levario said. "It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them."

Under the new ruling, the FDA has provided a list of ingredients foods must not contain in order to be labeled as "gluten-free." The typical ingredients are wheat, rye and barley, or crossbreeds of these grains. Ingredients that are derived from these grains that have not been processed to remove gluten also cannot be in the mix, nor can any ingredient derived from these grains that has 20 ppm or more of gluten.

Foods that inherently do not have gluten can be marked as "gluten-free." This includes foods such as bottled water, fruits, vegetables and eggs, as well as most foods that do not contain wheat, rye and/or barley, or its derivatives.

The regulation will be published on August 5 in the Federal Register and manufacturers will have one year to bring their labels into compliance. Taylor believes most companies already have "gluten-free" foods within the proper range and should have no problem adapting to the new rules. However, he adds, "We encourage the food industry to come into compliance with the rule as soon as possible."

"This is a huge victory for people with celiac disease," says Levario. "In fact, that's the understatement of the year."

Nita Lowey, D-Westchester, the congresswoman who first began arguing for labeling standards in 1999, applauded the new rule changes.

"I am pleased that our federal government has finally set clear, uniform standards that will rein in a fast-growing, unregulated market," Lowey said in a statement to USA Today's Elizabeth Weise.

Gluten-free foods have gained in popularity over the past five years and the market was estimated to be $4.2 billion in 2012, according to market research firm Packaged Facts. The group expects the gluten-free market to continue its upward climb, reaching $6.6 billion by 2017.

The FDA rules follow similar rules by the European Union and Canada, which have also set levels to fewer than 20 ppm for the gluten-free labels, noted Taylor.